FDA 510(k) Application Details - K220861

Device Classification Name	More FDA Info for this Device
510(K) Number	K220861
Device Name	M6-C Artificial Cervical Disc Instruments AS
Applicant	Spinal Kinetics LLC 501 Mercury Drive Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Joyce Zhong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2022
Decision Date	06/02/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review